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PubMed2002

Attitudes of the Japanese public and doctors towards use of archived information and samples without informed consent: preliminary findings based on focus group interviews.

BACKGROUND: The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing) materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research. METHODS: Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated. RESULTS: It was revealed that the lay public expressed diverse attitudes towards the use of archived information and samples without informed consent. Protecting a subject's privacy, maintaining confidentiality, and communicating the outcomes of studies to research subjects were regarded as essential preconditions if researchers were to have access to archived information and samples used for research without the specific informed consent of the subjects who provided the material. Although participating physicians thought that some kind of prior permission from subjects was desirable, they pointed out the difficulties involved in obtaining individual informed consent in each case. CONCLUSIONS: The present preliminary study indicates that the lay public and medical professionals may have different attitudes towards the use of archived information and samples without specific informed consent. This hypothesis, however, is derived from our focus groups interviews, and requires validation through research using a larger sample.

Attitude of Health Personnel↗

PubMed2006

Informed consent in the practice of group psychotherapy.

Endorsed as part of ethical practice in group psychotherapy by professional organizations, informed consent is a process of communicating essential information about group treatment to patients so that they can make rational decisions about treatment-whether to enter and how to participate. Its benefits as well as necessary precautions are discussed. The design and implementation of the informed consent process for group is discussed in terms of who should obtain it, when it should occur, how it should be communicated, and what information should be considered for inclusion. Specific suggestions are included as well as a discussion of some potential ethical dilemmas.

Decision Making↗

PubMed1997

[Patient information and obtaining informed consent in laparoscopic surgery].

Since the advent of laparoscopic surgery, the number of suits against surgeons has risen. One of the most frequent complaints is the lack of sufficient information. Physicians in France have a formal obligation to provide information in the contractual legal context established since 1936. This notion has been confirmed in several court cases. The requirement for patient informed consent has been confirmed by several decisions of the Appeals Court and is stated in the code of deontology. The value of classical oral information has been recently questioned in certain court cases. We analyse the current legal situation in France and try to define the content of information required in the case of laparoscopic surgery in addition to the way this information is provided and the means of obtaining informed consent. The information provided must be personalised. The patient must informed that laparoscopy remains a surgical operation. It is licit to warn the patient of predictable risks according to statistical probabilities, of the team's experience and of the patients own status including past history and psychological factors. A written statement may be prepared but must remain a document complementary to personalised oral information. The surgeon must obtain and assure good patient comprehension. The surgical community should publish risk rates in order for surgeons to have reliable references which can be used to define the notion of exceptional risk.

Cognition↗

PubMed2006

Medical devices; exception from general requirements for informed consent. Interim final rule.

The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.

Device Approval↗

PubMed2001

A survey of genetic counselors' use of informed consent documents for prenatal genetic counseling sessions.

Thirty six members of the Prenatal Diagnosis Special Interest Group of the National Society of Genetic Counselors were interviewed about their use of informed consent documents for the genetic counseling component of their prenatal genetic counseling sessions and their perceptions of the utility and feasibility of such documents. Major findings include (1) None of the genetic counselors currently used a consent document describing the genetic counseling component of the session itself; (2) Only three participants stated that they had ever used an informed consent document for this component of the session; (3) They disagreed about the importance and usefulness of such a document; (4) There was variability in their reported likelihood of using a document if one were available; (5) There was a fair amount of agreement about the types of information to include on an informed consent document for genetic counseling; over half of the sample endorsed 8 of 10 topics; and (6) Participants identified 10 obstacles to using such a document. Recommendations for genetic counseling practice, policy, and research are given.

Attitude of Health Personnel↗

PubMed2002

Informed consent and patient videotaping.

PURPOSE: To determine whether videotaping consent forms used in family medicine residencies meet the criteria for informed consent, adhere to published guidelines for videotaping patients, and are written at a suitable reading level. METHOD: Three reviewers independently evaluated videotaping consent forms obtained from 20 family practice residencies to determine whether they included the elements of informed consent and conformed to published guidelines for ethical videotaping. The reading level of each consent form was also determined using a standardized assessment. RESULTS: Depending on the reviewer, only one to three of the 20 consent forms were judged adequate in providing a patient with enough information to make an informed choice. Specific aspects of voluntariness were absent from most of the forms. In addition, the reading level was, on average, well above recommended levels for patient comprehension. CONCLUSION: Most of the videotaping consent forms analyzed in this study did not provide adequate information to assist patients in making a voluntary, informed choice to be videotaped. The absence of this information raises the potential for violations of patient privacy and confidentiality.

Confidentiality↗

PubMed2005

A prospective study comparing conventional methods against a structured method of gaining patients' informed consent for tonsillectomy.

OBJECTIVE: By providing junior members of medical staff with appropriate guidelines one can achieve an improved standard of informed consent for tonsillectomy, than is provided at present. DESIGN: A prospective study of 138 consecutive patients. SETTING: District General Hospital. PARTICIPANTS: A total of 138 patients undergoing routine tonsillectomy split into two groups. Group A (n=87), the conventional group, gave consent in our unit's standard manner to various grades of doctors by using a hospital general surgical consent form. Most gave their consent as outpatients, while some consented on admission. Group B (n=51), the structured consent group, gave their consent in pre-admission clinic, to an SHO using a standardized tonsillectomy consent form and a structured interview technique. MAIN OUTCOME MEASURES: A preoperative questionnaire regarding the knowledge of tonsillectomy. RESULTS: Improvement of the awareness of the risks involved with tonsillectomy was achieved by the structured consent Group B; 82% of Group A were aware of postoperative pain compared with 94% of group B (P=0.04); 63% of group A were aware of infection compared with 82% of group B (P=0.02); 100% of group B had read the consent form before signing compared with 80% of group A (P<0.01). There was no statistical difference in the awareness of postoperative haemorrhage (91 versus 98%, P=0.15). CONCLUSION: By providing junior medical staff with guidelines, senior staff retain responsibility for consent while improving the standard of informed consent for tonsillectomy.

Adolescent↗

PubMed1984

Changes in the concept of informed consent in medical encounters.

The author in this article reviews recent changes in the conceptualization of informed consent in medical encounters to help provide a better understanding of the concept itself and of some difficulties that exist in philosophical justifications for the requirement of informed consent.

Humans↗

PubMed1993

Readability of informed consent forms for use with iodinated contrast media.

Informed consent forms used before intravenous administration of contrast media by both private practice (Pennsylvania Blue Shield) and academic (Association of University Radiologists) physician groups were analyzed to evaluate for readability and content. Most of the 160 consent forms required at least a high school education to be understood; 10 (6%) required a college education. Consent forms from academic institutions tended to be longer and contain more problems with sentence structure than those from private practice. Consent forms from both groups tended to have a weak, wordy writing style. Although most of the consent forms discussed at least some of the potential adverse reactions from intravenous contrast media, 37 (23%) made no mention of any potential adverse reaction. Indeed, 25 (16%) made no mention of contrast media at all. Only 12 (8%) consent forms included a discussion of nonionic contrast media. The authors provide sample consent forms that cover the common risks of ionic and nonionic contrast media and describe the availability of nonionic contrast media; these forms are understandable by an individual reading at only an eighth-grade level.

Comprehension↗

PubMed2001

Quality of informed consent in cancer clinical trials: a cross-sectional survey.

BACKGROUND: Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers. METHODS: We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent. FINDINGS: 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise non-standard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. INTERPRETATION: Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.

Adult↗

PubMed1995

Parental perceptions and attitudes about informed consent in clinical research involving children.

We interviewed 64 parents by questionnaire after completion of a clinical trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realised that drug trials are designed to assess not only efficacy but safety as well. More worrisome was the majority of parents who felt that drug trials conducted by hospitals are of no or low risks. Moreover, a significant minority offered the view that the strict informed consent procedures we followed were unnecessary because they would do what the doctor advised. Even more worrisome was the small percentage of parents who realised that a signed consent form was primarily meant to protect their rights, and only one-third of the parents knew of their right to withdraw their child unconditionally from the trial at any time. These findings suggest that there may be significant attitudinal barriers to parental understanding of the informed consent process.

Adult↗

PubMed1995

Parental perceptions and attitudes about informed consent in clinical research involving children.

We interviewed 64 parents by questionnaire after completion of a clinical trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realized that drug trials are designed to assess not only efficacy but safety as well. More worrisome was the majority of parents who felt that drug trials conducted by hospitals are of no or low risks. Moreover, a significant minority offered the view that the strict informed consent procedures we followed were unnecessary because they would do what the doctor advised. Even more worrisome was the small percentage of parents who realized that a signed consent form was primarily meant to protect their rights, and only one-third of the parents knew of their right to withdraw their child unconditionally from the trial at any time. These findings suggest that there may be significant attitudinal barriers to parental understanding of the informed consent process.

Administration, Oral↗

PubMed1989

[The law of informed consent and its impasses in psychiatry].

Every medical intervention is submitted to the rule of informed consent. Over the years, criteria of consent validity and exception situations have been defined. After a discussion of the difficult application of the informed consent rule in psychiatry, this article suggests an analysis of the motivations of a refusal of neuroleptic medication in 20 psychotic patients of a psychiatric hospital. The irrational motivations of refusal (particularly, denial and delusional ideation) have been evoked much more often then rational motivations (therapeutic inefficiency, secondary effects). The authors question the denial as a sufficient reason to declare a psychotic patient incompetent to consent. The consequences of the refusal of the neuroleptic treatment in some patients, mainly the risk of criminalization, are discussed.

Antipsychotic Agents↗

PubMed1990

[Informed consent of the family in the chemotherapy for lung cancer].

In Japan where the question of cancer notification has yet to be resolved, it is difficult to obtain an informed consent from the patient himself in clinical studies of the chemotherapies for cancer. In fact, the chemotherapy is administered while not enough explanation is given to the family let alone the patient. Such is the present situation. For the purpose of finding out the best possible method at present, we carried out a method whereby an informed consent of the family is substituted for a consent of the patient in phase II study of inoperable non-small cell carcinoma of the lung. As a result, the consent was obtained from 21 (91.3%) out of 23 families. This method should be taken into consideration as a feasible one under the present circumstances. It was in only one family (4.3%) that a consent on the notification of diagnosis from the family to the patient was obtained. In order for the informed consent to be established, efforts to form a social consensus on cancer notification are needed.

Adult↗

PubMed2005

An ethical analysis of exception from informed consent regulations.

Federal regulations enacted in 1996 allow clinical research with an exception from informed consent in select emergency circumstances. Such research is only permitted when the therapy may directly benefit the research participant and it is not possible to conduct the research with informed consent. Among others, protective mechanisms include a process of community consultation and public disclosure and the establishment of a mandatory data safety monitoring board. Although the regulations do not preserve the right of self-determination of the research participant, the author argues that they do provide an ethical means to advance the science of resuscitation.

Beneficence↗

PubMed2004

Informed consent is not routinely documented for procedures using allografts.

Patients who receive musculoskeletal allografts may have severe postoperative infections develop. Media reports have heightened public awareness of the risk of allograft use. Explaining these risks to patients preoperatively has become more important as attention to informed consent issues has increased. This study retrospectively investigated the patterns of informed consent for allograft bone used during elective orthopaedic procedures at a major teaching hospital. Forty-seven (32%) of 148 patients had preoperative discussions of allograft risks and benefits documented with a signed preoperative consent. In nearly 70% of the cases in which structural allograft was used, preoperative consent was documented. Only 8% of cases in which nonstructural, highly processed allograft was used had documented preoperative consent. Forty-eight (32%) of 148 patients were treated with allograft and autograft. Consent was obtained for the harvesting and use of autograft from 90% of these patients. In none of these patients was consent obtained for the allograft used. Although risks of disease transmission vary widely with the degree of allograft processing and the source of its procurement, informed consent for any allograft use should be a routine part of preoperative discussions of risks and benefits in elective orthopaedic surgeries.

Bone Transplantation↗

PubMed1988

Informed consent and provider-patient relationships in rehabilitation medicine.

The legitimacy of paternalism in health care relationships has been severely criticized by those in the field of medical ethics. Critics have argued that paternalism has no place in physician/patient encounters. Patients must always be treated as autonomous agents, capable of directing the course of their medical care. Informed consent has come to represent the mechanism through which autonomy can best be assured in medical relationships. If provider/patient interactions are viewed as a contract between consenting agents, then providers are obligated to obtain informed consent for all interventions they wish to undertake. This view, however, relies upon examples of care provided to those with acute medical problems. In rehabilitation, it can be argued that for some patients at some times during their care, a contractual model would be inappropriate. Especially when patients have undergone a sudden and unexpected course of severe impairment, it is difficult to conceptualize provider/patient relationships in the context of a contract. Providers are more accurately seen as acting in educational roles toward those in their care. If this is so, then there may be instances in which paternalistic behavior toward rehabilitation patients is ethically justified. Informed consent must be carefully examined if it is to be a useful doctrine in the context of rehabilitative care.

Contracts↗

PubMed2003

Perceptions of autonomy, privacy and informed consent in the care of elderly people in five European countries: comparison and implications for the future.

This article discusses nurses' and elderly patients' perceptions of the realization of autonomy, privacy and informed consent in five European countries. Comparisons between the concepts and the countries indicated that both nurses and patients gave the highest ratings to privacy and the lowest to informed consent. There were differences between countries. According to the patient data, autonomy is best realized in Spain, privacy in the UK (Scotland), and informed consent in Finland. For the staff data, the best results tended to concentrate in the UK. The conceptual and methodological limitations of the study are identified and discussed. Implications of the results are divided into three areas: nursing practice, education and research. In practice, the analysis of patients' values and the ethical sensitivity of nurses are important as part of ethically good care. In nurse education, students should learn to recognize ethical problems, generally and particularly, among vulnerable groups of patients. Multicultural international research is needed in this area. This is the last of a set of five articles published together in this issue of Nursing Ethics in which the results of this comparative research project are presented.

Adult↗